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Completed

NCT Number: NCT02938169

The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis

The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Kyungji-do, 13620, South Korea

About this study

  • Design: Prospective study
  • Setting: hospital rehabilitation department
  • Intervention: Participants are randomly assigned 4 different exercise group: flexibility exercise, bracing exercise + stabilization exercise group, bracing exercise+ walking exercise group and bracing+ walking + stabilization exercise group
  • Main outcome measures: Numeric rating scale(NRS), Oswestry disability index Peak torque of lumbar extensor by surface electromyography Time duration of capability of maintenance the posture

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Age>20
  • Who suffered low back pain more than 3 months.
  • Exclusion Criteria:
  • Pregnancy
  • Under 20-year-old
  • Who have significant neurologic deficit
  • Who experienced spine operation
  • Who cannot walking

Treatment and study plan

Exercise

Behavioral
  • stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.
  • bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."
  • walking exercise: treadmill gait with tolerable gait speed
  • flexibility exercise: stretching exercise(control)

Primary outcomes

  1. Low Back Pain at Resting Status

    Time frame: Baseline Pre-Exercise and 6 weeks

    numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain).

  2. Disability for Low Back Pain

    Time frame: Baseline Pre-Exercise and 6 weeks

    Oswestry disability index(ODI) (Unit: Point) The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.[

  3. Visual Analog Scale of Low Back Pain During Rest

    Time frame: 0 week to 6weeks

    visual analog scale of low back pain during resting status at 0 week and 6 week Record 'no pain' on the left side of the line as 'unpaid pain' on the right side and indicate the degree of pain in the subject(0 to 100) 0 is equated with 'no pain' and 100 is 'unpaid pain'

Secondary outcomes

  1. Muscle Strength(Endurance)

    Time frame: Baseline Pre-Exercise and 6 weeks

    endurances of specific posture (sec) (supine, side-lying and prone)

  2. Depression Scale

    Time frame: 6 weeks

    Beck depression inventory consisted of 21 questions about how the subject has been feeling in the last week. Each question had a set of four possible responses, ranging in intensity(0 is weak and 3 is severe). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The total score is 63, higher total scores indicate more severe depressive symptoms.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: EMG

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2016
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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